Physical Activity and Ventricular Arrhythmias

St. Olavs Hospital55 enrolled

Overview

The purpose of the study is to determine the effect of aerobic interval training in patients with an implantable cardioverter defibrillator (ICD) on physical fitness, quality of life and the amount of serious ventricular arrhythmic events on short and long term.

In this study, participants will be randomly assigned to either take part in the exercise program or serve as control and live as usual. At baseline study visit, study researchers will review medical records to collect various information, including the reason for needing an ICD, the type and settings of the ICD, medication use and medical history etc. All participants will undergo blood collection, complete a questionnaire to assess quality of life and undergo examination with echocardiography and ECG. The ICD will be programmed accordingly to international guidelines regarding ICD-therapy and optimal monitoring, before each participant complete an exercise treadmill test to determine VO2 peak. They will wear a Holter monitor to record heart activity 48 hours before the test and 24 hours after the test. All participants will then be observed for 2 months before being randomly assigned to either intervention or control. During this observation period, they will wear a fitness activity tracker wristband to evaluate degree of physical activity and a Holter monitor to register number of premature ventricular contractions. Participants taking part in the interval training group will perform aerobic interval training 4 x 4 minutes intervals, 3 times a week for 12 weeks (week 1-12), whereas participants taking part in the control group will carry on with usual daily life with no lifestyle recommendations. All participants will then undergo a new period of observation (week 13-20) and repeat the tests and examinations performed at baseline and during the observation period prior to intervention/control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tachycardia, Ventricular Defibrillators, Implantable

Interventions

Interval exerciseBEHAVIORAL

Aerobic interval training during 12 weeks 3 times a week: 4 x 4 minutes intervals at an intensity of 90-95% of VO2 peak and active breaks of 3 minutes between intervals.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with ICD and dilated cardiomyopathy or coronary heart disease as cause for implantation * ICD implanted at St Olavs hospital, Trondheim In case of difficulties with patient inclusion for the study, the criteria might be broadened to include patients with idiopathic ventricular arrhythmia as cause for implantation. Exclusion Criteria: * inability to accomplish the exercise program due to serious comorbidity or to participate in regular training within the next 3 months due to other reasons * signs of severe cardiac ischemia or persistent ventricular tachycardia during individualized treadmill O2 peak test, which after individual assessment is to be found at risk * comorbidity where endurance training at more than moderate intensity is discouraged * severe cardiac valve disease * planned surgery within the next 3 months * inability to give informed consent

Locations (1)

St Olavs Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

Change in physical fitness/aerobic capacity

Expressed in and measured with maximal oxygen uptake (VO2 peak)

Time frame: Change from baseline and after ended intervention period (12 weeks)

Change in assessment of quality of life

Patient-reported survey of patient health SF-36

Time frame: Change from baseline and after intervention period (12 weeks)

Secondary Outcomes

Change in burden of ventricular arrhythmias from baseline to week 9-12

Evaluated by number of ICD discharges (registered on ICD)

Time frame: Baseline and the last 4 weeks of intervention period (week 9-12)

Change in burden of ventricular arrhythmias from baseline to week 13-16

Evaluated by number of ICD discharges (registered on ICD)

Time frame: Baseline and the first 4 weeks after intervention period (week 13-16)

Change in burden of ventricular arrhythmias from baseline to week 9-16

Evaluated by number of ICD discharges (registered on ICD)

Time frame: Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16)

Change in burden of ventricular arrhythmias from baseline to week 9-12

Evaluated by number of episodes with antitachycardia pacing (registered on ICD)

Time frame: Baseline and the last 4 weeks of intervention period (week 9-12)

Change in burden of ventricular arrhythmias from baseline to week 13-16

Evaluated by number of episodes with antitachycardia pacing (registered on ICD)

Data from ClinicalTrials.gov

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Time frame: Baseline and the first 4 weeks after intervention period (week 13-16)

Change in burden of ventricular arrhythmias from baseline to week 9-16

Evaluated by number of episodes with antitachycardia pacing (registered on ICD)

Time frame: Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16)

Change in burden of ventricular arrhythmias from baseline to week 9-12

Evaluated by number of episodes with monitored ventricular tachycardias without ICD-therapy (registered on ICD)